MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; SPINAL CORD STIMULATOR

Model Number SC-1110-02

Device Problems Bent (1059); High impedance (1291); Kinked (1339); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2218-70 serial#: (b)(4) description: linear st lead, 70cm model#: sc-4316 lot#: 14302399 description: next generation anchor kit-sterile.

Event Description

A report was received that the patient's lead contacts had high impedances.The patient underwent a revision procedure wherein the leads and clik anchor were replaced.The ipg was also replaced for an unknown reason.Device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the reason for the ipg replacement procedure was due to the high impedances.

Event Description

A report was received that the patient's lead contacts had high impedances.The patient underwent a revision procedure wherein the leads and clik anchor were replaced.The ipg was also replaced for an unknown reason.Device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-1110-02 (sn (b)(4)): device evaluation indicated that the ipg passed all the required tests and revealed no anomalies.Sc-2218-70 (sn (b)(4)): device evaluation indicated that the complaint was confirmed.Visual and x-ray inspections of the lead found cable fractures at the kinked sections of the lead body where the clik anchor was positioned.Fracture location was 1 cm from the setscrew mark.There were no cables are exposed.In addition, the lead was cut and the proximal tip was not returned.Several cables were pulled and exposed.Cut damage to the lead is a result of a typical explant procedure and it was not considered a failure.Sc-4316 (ln 14302399): device evaluation revealed both eyelets of the clik anchor were damaged, and the part of silicon material from eyelets were missing.Additional information was received that there were no further information that can be obtained with regards to the missing silicone and no further course of action at this time for it.

Event Description

A report was received that the patient's lead contacts had high impedances.The patient underwent a revision procedure wherein the leads and clik anchor were replaced.The ipg was also replaced for an unknown reason.Device malfunction was suspected.The patient was doing well postoperatively.

• Brand Name: PRECISION®
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6256278
• MDR Text Key: 64933031
• Report Number: 3006630150-2017-00188
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: (01)08714729767688(17)130601(10)14372529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2013
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/25/2017; 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR